Exemption from the requirements for labelling, implementation deadlines, package leaflets etc. for medicinal products

An exemption is a temporary authorisation from the Danish Medicines Agency to sell an authorised medicinal product in Denmark when the product does not meet the statutory requirements for labelling, package leaflet etc.

Pharmaceutical companies are required to apply for exemption to the Danish Medicines Agency if, for a temporary period of time, they wish to market packages that do not meet the requirements for labelling, package leaflet etc. for medicinal products.

This could be the case for packages of medicine which

• contain labelling or package leaflet errors
• are in a foreign language
• include an old version of the labelling or package leaflet 

When are exemptions granted?

The Danish Medicines Agency assesses each specific application and the circumstances of the case. Exemption is granted in special circumstances and subject to terms established in the specific case. Exemption is granted for a limited period of time only.

Exemptions permitting the sale of foreign packages or medicinal products not meeting the requirements for labelling, package leaflet, etc. may, for example, be granted if the medicinal product would otherwise go out of stock, no obvious alternatives exist and patients therefore cannot continue treatment.

Exemptions are generally not granted for the sale of foreign packages if the medicinal product has not previously been marketed in Denmark.

In its assessment of the case, the Danish Medicines Agency takes particular account of the following criteria

• whether there are consequences for patient safety if exemption is granted
• whether there are available alternative medicinal products on the Danish market
• whether the medicinal product is considered critical to the Danish market
• whether it is a prescription-only or an over-the-counter medicinal product
• whether the medicinal product is administered by patients or healthcare professional

If the application concerns temporary sale of foreign packages, the applicant must be aware that an exemption permitting the sale of a foreign package is subject to additional labelling, i.e. a sticker with the Danish product number (Vnr) and a Danish MA number on the outer packaging.

In addition, exemption may in some cases be subject to further additional labelling.

Application for exemption

The application must include information about

• a power of attorney if the application is submitted by someone other than the authorised marketing authorisation holder or their representative
• the background to the application, e.g. supply disruption, failure to implement information/changes to the packaging material resulting from a variation application or an order
• a justification for the application, i.e. why the established deadline or the general rules cannot be met
• a description of the precautions taken by the applicant to prevent a similar situation from happening again
• the duration of exemption
• number of packages
• the difference between the present package leaflet supplied with the packages and the most recently approved version (include a version with tracked changes)
• a copy/image of the package/labelling that will be used instead, including the language of the material if involving a foreign package and a description of any differences
• the consequences for patient safety if exemption is granted
• a copy, if relevant, of the Danish Medicines Authority’s decision that gave rise to the application for exemption

In the case of an exemption application to extend the implementation deadline of a variation, the application must be submitted in sufficient time for the Danish Medicines Agency to assess the application before the expiry of the implementation deadline set by the agency.

The application must be submitted electronically to the Danish Medicines Agency via Send an email.

We aim to review the application within 10 business days.

With reference to the guidelines on the Danish Medicines Agency’s website Notification duty in the event of medicines supply shortages please assess whether the supply issue should be reported to the Danish Medicines Agency. If so, please report the shortage via the link on the webpage.

Repackaging

In the case of additional labelling etc. a minor repackaging may be required.

See our guidance Temporary repackaging of medicines with a marketing authorisation